Z-2457-2015Class II

RayStation 4.7, version 4.7.1, used with Structure Definition or Automatic Breast Planning. Radiation Therapy...

Name: Z-2457-2015 RayStation 4.7, version 4.7.1, used with Structure Definition or Automatic Breast Planning. Radiation Therapy...
Creator: Raysearch Laboratories Ab
Published: 2015-05-27
License: https://open.fda.gov/license/

RaySearch Laboratories AB (publ) / initiated 2015-05-27 / Terminated / root cause: software

FDA source

RAYSEARCH LABORATORIES AB began a recall of RayStation 4.7, version 4.7.1, used with Structure Definition or Automatic Breast Planning. Radiation Therapy Treatment Planning System, for treatment planning... on 2015-05-27. FDA classified it as Class II and gives the reason as "Issue with the algorithm for ROI contraction in RayStation 4.7 when non-uniform contraction distances are used. The ROI contraction tool uses six distances as input: right/left, inferior/superior and posterior/anterior...". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as software.

Recall record

Recall number: Z-2457-2015
Classification: Class II
Status: Terminated
Initiated: 2015-05-27
Posted: 2015-08-25
Terminated: 2017-09-22
Recalling firm: RaySearch Laboratories AB (publ)
Product: RayStation 4.7, version 4.7.1, used with Structure Definition or Automatic Breast Planning. Radiation Therapy Treatment Planning System, for treatment planning and analysis of radiation therapy.
Product code: MUJ System, Planning, Radiation Therapy Treatment
Reason for recall: Issue with the algorithm for ROI contraction in RayStation 4.7 when non-uniform contraction distances are used. The ROI contraction tool uses six distances as input: right/left, inferior/superior and posterior/anterior. These contraction distances are, in error, pairwise reversed, i.e. right is interpreted as left, inferior is interpreted as superior, and posterior is interpreted as anterior.
Root cause tag: software
FDA root cause: Software design
Action: On May 27, 2015 RaySearch Laboratories distributed Medical Device Correction notices to their customers via courier service. Within the Medical Device Correction notice, RaySearch Laboratories included a workaround to the problem for their customers. Customers should not use structure templates containing derived ROI definitions with non-uniform contractions. They should avoid using non-uniform contractions. In the case non-uniform contractions must be used, enter switched distances manually and review the result carefully before using it for treatment planning. Lastly, do not use humerus shielding in Automatic Breast Planning. Customers are also expected to complete and return the lower portion of the correction notice via fax to 888-501-7195. **CAPA** Correct the software problem in patch version 4.7.2 of RayStation 4.7, scheduled for market release June 2015.
Quantity in commerce: 126 programs
Distribution: Distributed in CO, IL, MI, NC, OH,TN, and WA.
Product codes and lots: software build numbers are 4.7.1.10

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2457-2015
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2457-2015	Class II	Terminated	Voluntary: Firm initiated	2015-09-02	2015-08-25

Product code MUJ

K141860Class IIRaystationRaysearch Laboratories AB / cleared 2014-10-23

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-10-14, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)